FDA approves new anti-abuse Zohydro ER hydrocodone

March 11, 2015
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Novus Medical Detox Center

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Zohydro ER, the extended release hydrocodone prescription painkiller that caused a firestorm when the FDA approved it over a year ago, has finally been released in a new abuse-resistant formulation. An extended release painkiller contains 5 or 6 times as much opioid as a single-dose pill. It’s intended to be released slowly over many hours after you take it. But addicts want to get all that opioid in a single hit by crushing it into a powder and snorting it, or mixing it in a liquid and shooting it up with a syringe. The new Zohydro ER is made using something called BeadTek technology, which is designed to deter abuse “without changing the release properties of hydrocodone when Zohydro ER is used as intended,” says the announcement from the pill’s maker, Zoegenix, Inc., of San Diego, CA. The company claims that, when the new pill is crushed and mixed into a liquid or solvent, the BeadTek technology turns it into a viscous gel that’s impossible to use in a syringe. The product label won’t include the abuse-deterrence claim until later in the year after the company finishes “Human Abuse Liability studies” of the pill’s new abuse-deterrent properties and submits the results to the FDA. These findings will affect the wording for the label.

Original FDA approval ignited a firestorm

Zohydro ER, the first pure hydrocodone extended release pill ever, with no abuse deterrence at all, was asking the FDA for approval to bring it to market. We already knew that hydrocodone was the most abused prescription opioid in America – even mixed, as it always was with acetaminophen in drugs like Lortab, Norco and Vicodin. Also, the country had already endured the horrors unleashed by Purdue Pharma’s OxyContin – a pure oxycodone extended release painkiller that triggered a decade of addictions, overdose deaths and ruined lives across the country. Purdue Pharma had come out with an anti-abuse version of OxyContin back in 2012, and it was seen as making a difference. Well actually, sending most addicts on to heroin or over to the various other painkillers like hydrocodone, hydromorphone and others. But now, here came Zohydro ER, pure hydrocodone with no built-in deterrence. It looked to everyone concerned like OxyContin all over again. The FDA’s approval of the original Zohydro ER ignited a firestorm of adverse reaction in the media, letters to the FDA from institutions all over the country, even demands that the head of the FDA resign. Criticism came not just from the public, but also from a wide cross-section of the medical profession. The consensus was that Zohydro ER offered nothing but more danger of abuse and deaths from overdose, since there was no real need seen for more opioid painkillers. Not only did the FDA approve Zohydro ER as-is in the face of all this criticism, it did so against the direct recommendation of its own medical, scientific and research advisory committee to disapprove the drug and keep it off the market.

DEA classifies hydrocodone as even more dangerous

Last year, not too long after the FDA approved the original Zohydro ER and after more than a decade of hemming and hawing, the Drug Enforcement Administration (DEA) finally rescheduled hydrocodone-containing meds as Schedule II drugs, up from Schedule III. In plain English, this meant it was finally acknowledged that hydrocodone is just as dangerous as oxycodone, which has always been Schedule II. We at Novus were pleased to report on the DEA rescheduling of hydrocodone, since we see the harm that hydrocodone has brought to so many of our patients. Hydrocodone is among the top killer drugs in America. And believe it or not, 99 percent of all hydrocodone is consumed right here in America. The rest of the world just isn’t interested, because there are plenty of other prescription opioids to choose from. And many, if not most pain management specialists, even here in America, question the need for more. Also, late last year, Purdue Pharma came out with its own anti-abuse hydrocodone extended release painkiller, with the company’s abuse-resistance technology built in. Called Hysingla ER, it’s abuse-deterrent technology “discourages” chewing, crushing, snorting or injecting.

Even a legitimate prescription can lead to hydrocodone dependence

Let’s not forget that there are many medical patients who take legitimate, doctor-ordered hydrocodone or other opioids for pain, who then become dependent on the drugs – abuse-resistant or not. These people need to be carefully weaned off those drugs, but some of them actually become addicted. So here we are, in a country awash in prescription opioid painkillers (there are dozens) and countless thousands of prescription opioid painkiller addicts, and we have not one, but two new ones. And doctors often find themselves stuck between a rock and a hard place – wanting to help their patients, but at the same time wanting to avoid over-medicating with seriously addictive painkillers. There is a movement afoot among pain specialists and researchers to find solutions for mild and moderate pain other than opioids and opiates. Some approaches are already being used, but it’s rough going when the American public is demanding opioids, and nearly all regular doctors know very little about alternatives. Perhaps this will be the subject of a future blog. Meanwhile, here at Novus, we’re known far and wide for our medical breakthroughs in opioid detoxification, including hydrocodone. Our proprietary opioid detox protocols result in much more comfortable detox experiences for our patients, and even improves patients’ overall health. Patients often remark as they’re leaving, “I haven’t felt this good in years, even before I got into trouble with (substance abuse).” If you or someone you care for has a problem with opioid dependence or addiction, don’t hesitate to call us. We are always here to help.

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